Sen. Harkin has ‘high hopes’ for drug safety bill

WASHINGTON — The chairman of the Senate Health, Education, Labor and Pensions Committee highlighted the human tragedy wrought by last year’s fungal meningitis outbreak linked to contaminated injectable steroids as he spoke in favor of a new law that would regulate compounding pharmacies and implement federal track-and-trace policies for drugs during a recent speech.

Sen. Tom Harkin, D-Iowa, expressed "high hopes" that the Senate would vote to enact the Drug Quality and Security Act, which is designed to ensure the safety of compounded drugs and secure the pharmaceutical supply chain and was cosponsored by Senate HELP Committee ranking member Lamar Alexander, R-Tenn. The bill has received support from the National Association of Chain Drug Stores, the National Community Pharmacists Association and the Generic Pharmaceutical Association.

"The 751 patients who were sickened by contaminated injections sold by [the New England Compoundint Center] and the families of the 64 who have died have lived a nightmare over this past year," Harkin said in the speech. "The medicine that was supposed to help them made them gravely ill or, in far too many cases, took their lives."

Harkin highlighted the cases of four patients who have had to quit their jobs due to unrelenting chronic pain, whose children have had to quit their jobs to take care of them, or who have lost their lives. He called the compounding provisions in the legislation an "unqualified step forward" from current law and practice, emphasizing that it distinguishes between traditional compounding and compounding that produces large volumes of drugs without individual prescriptions. Under the law, compounding pharmacies that perform such outsourcing services would be subject to Food and Drug Administration regulations, while those that engage in traditional compounding would continue to be regulated by the state boards of pharmacy.

Meanwhile, the bill’s track-and-trace provisions "will revolutionize the pharmaceutical supply chain," Harkin said, saying it would complete the work of last year’s FDA user-fee bill, which includes provisions to modernize the FDA’s authority regarding the so-called upstream supply chain, meaning the path of drugs from raw materials to finished products. The new bill, Harkin said, would modernize the downstream supply chain, meaning the path drugs take from manufacturers to providers and patients.

"The last comprehensive effort to establish safeguards for the drug distribution supply chain was 25 years ago," Harkin said.

Title II of the Bill is a real problem. Given the history of drug counterfeiting it is very likely there will be a highly publicized drug counterfeiting issue before the next congressional elections. Last fall counterfeit cancer medication meant that cancer patients were not receiving active medication. In the past, patients were killed when heparin was counterfeited, children killed when cough syrup contained the main ingredient of antifreeze, etc.
Senators who approve of the nicely titled Drug Quality and Security Act (DQSA), H.R. 3204, will likely have to explain Title II of the Bill and why they allowed Big Pharma and Drug Wholesalers to get away with weak controls of prescription drug trade. Try explaining that to the parents of a child harmed by counterfeiting. Someone in the media will likely point out how weak the US drug controls are when compared with other countries.
While Mr. Reid praises Title I of the Bill to control compounding he completely ignores how damaging Title II is to assuring the safety and authenticity of the US prescription drug trade. This is likely due to the extensive lobby effort to slip Title II of the Bill through by including something many wanted in the form of Title I of the Bill.
It is much harder to defend Title II because many other countries require prescription drugs to be individually serialized and each sale of the drug to be certified and tracked. If H.R.3204 is passed the US will delay implementation of drug tracking by 10-years. The US drug supply tracking controls will be weaker than Turkey, China, Europe and several other countries. Why should the US citizens tolerate this or compromise? This should be part of the debate.
If a Senator is seeking election or believes US patients deserve better, we implore them to break H.R.3204 into two separate Bills and consider compounding controls (Title I) and drug supply chain controls (Title II) separately. We further ask that they require guidance from the FDA for drug tracking in 2 years instead of 10 years and implementation by 2017. This would at least bring the US in line with other countries.
Another unmentioned irony is that drug companies will have to serialize and track drugs for other countries and are upgrading their systems to do this now, but H.R. 3204 will allow them to avoid using those systems to protect US citizens. In fact, because the tracking requirements will be defined over the next 10 years, drug companies will not invest in tracking drugs in the US out of concerns that the FDA will require something different and they will have to throw away their investment in favor of something else.
All the FDA needs to do is consider the tracking model that was developed for a California law to track each trade of drugs using serialization (scheduled to begin in 2015 but will be preempted by H.R. 3204 and blocked). The FDA should consider the models from many other countries that require tracking and serialization. This should be able to be accomplished in less than 2 years. Drug companies should be required to serialize drugs to comply with the March 2010, FDA guidance for serial numeric identifier (SNI) on drug products by 2016 (they were doing that to comply with California Law anyway). The drug companies should be required to track the change of custody of each drug item by 2017. This is important and patients are at risk now.
Senators or either party seeking reelection will need to explain many things, adding H.R. 3204 weak prescription drug controls compared with other countries to explaining the shutdown and Affordable Care Act implementation may be more than their electorate will tolerate.
Please – do not vote for H.R.3204 due to Title II.
READ MORE FROM OTHERS AND SEE WHY WE ARE RIGHT:
See what other countries are doing to track drugs: http://www.gs1.org/sites/default/files/docs/healthcare/13_GS1_HC_RefBook2013_All.pdf
Industry is ready for unit serialization in life sciences: http://www.pharmaceuticalcommerce.com/index.php?pg=business_finance&articleid=26845&keyword=manufacturers-serialization-traceability
Leading life sciences companies promised to be ready to provide serialized and tracked drug products in 2008. Why are we waiting so long? http://www.pharmacy.ca.gov/publications/ridleythomasletter.pdf
Purdue Pharma: Learn how leading pharmaceutical manufacturer is combating counterfeiting and diversion of drugs in the healthcare supply chain with GS1 Standards. http://www.gs1us.org/Portals/0/gs1%20us%20library/case%20studies/Purdue%20Pharma%20-%20Improving%20Patient%20Safety%20and%20Supply%20Chain%20Efficiency.pdf
EMD Serono: Learn how GS1 Standards-based solutions help a leading biopharmaceutical company to secure its global supply chain. http://www.gs1us.org/Portals/0/gs1%20us%20library/sectors/healthcare/industry%20use%20cases/EMD%20Serono%20Case%20Study.pdf
McKinsey Healthcare Report: The McKinsey & Company report, Strength in unity: The promise of global standards in healthcare, estimates the benefits - in lives and value - of implementing one single global standard in healthcare. http://www.gs1.org/docs/healthcare/McKinsey_Healthcare_Report_Strength_in_Unity.pdf
We have been discussing this topic in the US for many years. Why delay traceability by 10 more years? http://www.packworld.com/machinery/labeling/pedigree-paralysis-no-more

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WOONSOCKET, R.I. — A new study conducted by researchers at CVS Caremark and Brigham and Women’s Hospital explored the impact of genetic testing on prescribing patterns for cardiovascular therapy and found that there is an opportunity to improve upon the information physicians and patients receive on the evolving body of evidence for pharmacogenomics.

The study, published in the November issue of the American Heart Association journal Circulation: Cardiovascular Quality and Outcomes, found that only 1-out-of-5 patients who tested as poor metabolizers of the blood thinner clopidogrel had their antiplatelet therapy changed as recommended by the FDA. In addition, the study found that prescribers declined genetic testing in 25% of cases evaluated, while less than 10% of patients who were directly offered the genetic evaluation declined testing. The researchers concluded that the prescribing patterns noted in the study likely reflect the unclear impact and physician uncertainty regarding the evidence for pharmacogenomics.

"We’re entering an age when we can begin to create tailored treatment regimens for individual patients, but a genetic test is only valuable when providers and their patients can understand and act on the results," Troyen A. Brennan, EVP and chief medical officer of CVS Caremark and a study co-author, said. "This research shows there is an opportunity to improve upon the information doctors and patients receive on this evolving topic so that they can make the best treatment decisions."

The study examined prescribing patterns for patients with recent acute coronary syndrome or percutaneous coronary intervention who were prescribed the antiplatelet medication clopidogrel. While clopidogrel has been shown to reduce the risk of major adverse cardiovascular events for these patients, there is significant variability in how individual patients respond to the drug. In fact, patients who are poor metabolizers of clopidogrel may have reduced therapeutic benefit and a higher risk of adverse cardiovascular events. The FDA has advised avoiding the use of clopidogrel in patients who are poor metabolizers and recently modified the boxed warning to advise health care professionals to consider the use of other antiplatelet medications or alternative dosing strategies for poor metabolizers.

Health care providers were offered access to a genetic test as part of the patient’s health benefit to identify the patient’s ability to metabolize clopidogrel. Nearly 500 patients completed the test, with approximately one-third of patients identified as being poor drug metabolizers. While the patients who underwent genetic testing were significantly more likely to have their antiplatelet regimen changed as compared with patients who did not undergo testing, only 20.5% of patients identified as being poor metabolizers had their antiplatelet therapy intensified or changed to another drug.

"In this study, about half of the providers that were contacted about the availability of a genetic testing benefit did not respond at all, and among those who did decide to use the test, the vast majority of patients identified as poor metabolizers did not have a change in therapy despite FDA warnings suggesting that they should," added Niteesh K. Choudhry, associate physician, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, associate professor, Harvard Medical School and the study’s senior investigator. "While there is significant uncertainty about how clinician’s should respond to the results of genetic testing for antiplatelet drugs, this study clearly shows that patients and their doctors need more guidance and education about how best to apply these results to improve patient outcomes."

SAN DIEGO — The Food and Drug Administration has given special designation to a drug under development by Mast Therapeutics for a rare disease that restricts the flow of blood to the limbs.

Mast announced Wednesday that the FDA had granted its drug, MST-188, orphan drug designation as a treatment for acute limb ischemia. The FDA grants the designation to treatments for diseases that affect 200,000 or fewer people. Acute limb ischemia results from embolism or thrombosis and is estimated to affect 14 out of every 100,000 people in the United States each year, according to a 1999 study.

"This designation represents further progress in our development of MST-188 as an adjunct therapy for life-threatening conditions treated with existing thrombolytic agents, such as [tissue plasminogen activator]," Mast CEO Brian Culley said. "As we previously reported, we are on track to initiate a phase-2, clinical proof-of-concept study in acute limb ischemia in early 2014."

As part of a panel at the recent Drug Store News Industry Issues Summit, officials from Walmart and Kroger shared the ways the two organizations go about taking a collaborative approach to health care.

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